Penile prosthesis and method

ABSTRACT

The penile prosthesis includes proximal and distal end portions with an intermediate normally flexible, nondistensible, collapsible main body portion that adjoins the proximal and distal portions. The main body portion includes filler elements that, in some embodiments of the invention, limit radial expansion of a rigidification chamber of the main body portion, and in other embodiments, limit radial constriction of the rigidification chamber. In some embodiments of the invention, rigidification is accomplished by movement of fluid into a rigidification chamber and in other embodiments of the invention rigidification is accomplished by movement of fluid out of a rigidification chamber. The prosthesis includes a manually manipulable pumping arrangment to establish the necessary fluid movement for development of an erectile condition or a flaccid condition as desired.

BACKGROUND OF THE INVENTION

This invention relates to penile erection systems for individuals whohave erectile dysfunction and more particularly to a novel penileprosthesis and method for supporting the penis in an erectile position,when desired, and permitting the penis to return to a flaccid condition,when desired.

Prosthetic devices for supporting the penis in an erectile conditionhave long been used to compensate for erectile dysfunctions thatotherwise prevent an individual from having an erection.

Generally, penile prostheses which support the penis in an erectilecondition also permit the penis to assume a flaccid posture when theerectile posture is no longer desired. U.S. Pat. Nos. 3,893,465 and4,151,840 show penile prostheses that include a relatively rigid memberthat supports the penis in an erectile condition and can also be bent tomaintain the penis in a flaccid posture. However, the flexural stiffnessof these prosthetic devices prevent the penis from having the freeflexibility that is normally associated with a flaccid penis, and thusdo not provide the comfort of a flaccid penis.

U.S Pat. Nos. 4,201,202 and 4,558,693 include a combination of aflexible elongated rod surrounded by a fluid expandable chamber. Howeverthe flexible rod must be bent to place the penis in a flaccid conditionand also does not provide the comfort of a flaccid penis.

Ideally a penile prosthesis should permit restoration of the penis to aflexible flaccid condition when an erectile condition is no longerdesired. Fluid inflatable or expandable erectile devices such as shownin U.S. Pat. Nos. 4,009,711; 4,267,829 and 4,383,525 rely on thepresence of fluid in a rigidification chamber to establish an erectilecondition. The expulsion of fluid from the rigidification chamber helpsestablish a flaccid condition of the penis. However, such devicesgenerally require a substantial amount of fluid and/or a substantialamount of fluid pressure within a rigidification chamber to achieve anerectile condition. As a result, the rigidification chamber wall must bereinforced as for example, by using a laminate construction such asdisclosed in U.S. Pat. No. 4,267,829. The reinforced chamber wall has apredetermined stiffness that limits flexibility of the prosthesis evenwhen the amount of pressure or fluid in the rigidification chamber isreduced. Thus, the flaccid condition of the prosthesis is limited inflexibility by the inherent stiffness of the reinforced chamber wall.

It is thus desirable to provide a penile prosthesis that can be placedin an erectile condition at a relatively low pressure and does notrequire flexibility-limiting reinforced walls to contain the pressure ina rigidification chamber.

As used herein, the term "flaccid condition" refers to a flexiblecondition of the prosthesis that corresponds to a flaccid penilecondition. The term "erectile condition" as used herein refers to arigid condition of the prosthesis that enables the prosthesis to assumea posture analogous to that of an erectile condition of the penis.

OBJECTS AND SUMMARY OF THE INVENTION

Among the several objects of the invention may be noted the provision ofa novel penile prosthesis, a novel penile prosthesis that can be placedin an erectile condition upon infusion of fluid into a rigidificationchamber, a novel penile prosthesis that can be placed into an erectilecondition upon expulsion of fluid from a rigidification chamber, a novelpenile prosthesis having filler means in a rigidification chamber fordetermining a limit in the radial magnitude of the rigidificationchamber, a novel penile prosthesis with filler means for limiting radialexpansion of a rigidification chamber, a novel penile prosthesis withfiller means for limiting radial constriction of a rigidificationchamber, a novel penile prosthesis with filler material in a chamber topermit rigidification of the chamber upon transfer of small volumes offluid into the chamber, a novel penile prosthesis with filler materialin a chamber to permit rigidification of the chamber upon transfer ofsmall volumes of fluid out of the chamber, and a novel method ofselectively establishing a flaccid or rigid condition in a penileprosthesis.

The penile prosthesis includes proximal and distal end portions with anormally flexible main body portion adjoining the proximal and distalend portions. The main body portion includes at least one sleeve thatdefines a sleeve chamber that includes filler material for limitingchange in the radial dimension of the chamber beyond a predeterminedlimit.

In some embodiments of the invention the filler material is arranged tolimit radial expansion of the chamber and in other embodiments of theinvention the filler material is arranged to limit radial constrictionor collapse of the chamber.

In the embodiments with filler material for limiting radial expansion ofthe chamber, rigidification of the chamber and consequentialrigidification of the prosthesis is accomplished by filling the chamberto an expansion limit condition. The fluid needed to reach the expansionlimit condition is less than the volume of the chamber by an amountsubstantially equivalent to the volume of filler material. The fillermaterial for limiting radial expansion of the chamber can includewebbing, which in some embodiments is axially elongated and radiallycorrugated, and in other embodiments is in the form of disks.

In several embodiments of the invention which incorporate fillermaterial for limiting radial constriction of the chamber, rigidificationof the prosthesis is accomplished by expelling fluid from the chamber tocause the chamber to constrict to a constriction limit condition. Theamount of fluid expelled from the chamber to cause the chamber to reachthe constriction limit condition is less than the volume of the chamberby an amount substantially equivalent to the volume of filler material.The filler material for limiting constriction of the chamber can includean aggregation of fibers, strands, beads, spheres, and other objects ofregular or irregular shape which occupy space in the chamber.

When fluid is present in the chamber, the chamber volume is maximized topermit relative movement between the individual particles or members ofthe aggregate. When fluid is removed from the chamber containing theaggregate, fluid pressure in the chamber is reduced, and the chamberwalls constrict or collapse around the aggregate to bind the aggregateand prevent any relative movement between the individual particles ormembers of the aggregate. Thus a rigidification condition is establishedin the chamber when the volume of fluid in the chamber is minimized.

In all embodiments of the invention the development of a rigidificationcondition in any of the chambers of the main body portion will place theprosthesis in a substantially inflexible, rigid condition that willsupport the penis in an erectile condition.

In some embodiments of the invention the main body portion includes onesleeve chamber and in other embodiments of the invention the main bodyportion of the prosthesis includes two sleeve chambers.

Pumping means for pumping fluid into or out of the sleeve chambers toaccomplish rigidification of the prosthesis can be provided at aproximal end of the prosthesis in some embodiments, and at a distal endof the prosthesis in another embodiment. In further embodiments, thepumping means can be provided at a remote location from the pendulousportion of the prosthesis as, for example, in the scrotal sac.

In all embodiments of the invention the development of a flaccidcondition or an erectile condition is accomplished through manualmanipulation of the prosthesis through the penile tissue or through thescrotal sac. Thus the user can achieve a flaccid or erectile conditionas desired.

The invention accordingly comprises the constructions and methodhereinafter described, the scope of the invention being indicated in theclaims.

DESCRIPTION OF THE DRAWINGS

In the accompanying drawings,

FIG. 1 is a simplified schematic view of a penile prosthesis, partlyshown in section, incorporating one embodiment of the invention andshowing a transitioning of the penile prosthesis from a positioncorresponding to a condition of penile flaccidity (hereinafter referredto as "flaccid condition"), to a position corresponding to an erectilecondition of the penis, (hereinafter referred to as "erectilecondition") during a pumping operation;

FIG. 2 is a fragmentary detail thereof, similar to FIG. 1, duringanother stage of the pumping operation;

FIG. 3 is a simplified schematic view thereof, partly shown in section,in an erectile condition and showing transitioning of the prosthesisfrom the erectile condition to a flaccid condition;

FIG. 4 is a sectional view thereof taken on the line 4--4 of FIG. 3;

FIG. 5 is a simplified schematic view, partly shown in section, ofanother embodiment of the invention showing the transitioning of theprosthesis from a flaccid condition to an erectile condition, during apumping operation;

FIG. 6 is a fragmentary detail thereof, similar to FIG. 5, duringanother stage of the pumping operation;

FIG. 7 is a simplified schematic view thereof, partly shown in section,in an erectile condition and showing transitioning of the prosthesisfrom the erectile condition to a flaccid condition;

FIG. 8 is a sectional view taken on the line 8--8 of FIG. 7;

FIG. 9 is a simplified schematic view, partly shown in section, ofanother embodiment of the invention, showing the transitioning of theprosthesis from a flaccid condition to the erectile condition during apumping operation;

FIG. 10 is a fragmentary detail thereof similar to FIG. 9, duringanother stage of the pumping operation;

FIG. 11 is a simplified schematic view thereof, partly shown in section,in an erectile condition and showing transitioning of the prosthesisfrom the erectile condition to a flaccid condition;

FIG. 12 is a sectional view taken on the line 12--12 of FIG. 11.

FIG. 13 is a simplified schematic view, partly shown in section, ofanother embodiment of the invention wherein the prosthesis is in aflaccid condition.

FIG. 14 is an enlarged fragmentary detail thereof, partly shown insection, in a flaccid condition;

FIG. 15 is a view similar to FIG. 14 during a pumping operation forplacing the prosthesis in an erectile condition;

FIG. 16 is a sectional view taken on the line 16--16 of FIG. 14;

FIG. 17 is a view similar to FIG. 15 during another stage of the pumpingoperation;

FIG. 18 is a sectional view taken on the line 18--18 of FIG. 17;

FIG. 19 is a view similar to FIG. 13 showing the prosthesis in anerectile condition and being manipulated for transitioning to a flaccidcondition;

FIG. 20 is an enlarged detailed sectional view thereof after beingmanipulated as shown in FIG. 19;

FIGS. 21-26 are detail views showing a subassembly thereof;

FIG. 27 is a simplified schematic view, partly shown in section, ofanother embodiment of the invention, in a flaccid condition;

FIG. 28 is a view similar to FIG. 27 during a pumping operation forplacing the prosthesis in an erectile condition;

FIG. 29 is a view similar to FIG. 27 showing the prosthesis in anerectile condition;

FIG. 30 is an enlarged detailed sectional view showing a valvearrangement thereof;

FIG. 31 is a simplified schematic view thereof, partly shown in section,during manipulation to transition the prosthesis from the erectilecondition to the flaccid condition;

FIG. 32 is similar to FIG. 30 showing valve distortion after beingmanipulated as shown in FIG. 31;

FIG. 33 is a view similar to FIG. 31 showing the prosthesis in a flaccidcondition;

FIG. 34 is a simplified schematic view, partly shown in section, ofanother embodiment of the invention, during a pumping operation toestablish an erectile condition;

FIG. 35 is a view similar to FIG. 34 showing the prosthesis in aerectile condition;

FIG. 36 is a view similar to FIG. 35 showing the prosthesis beingmanipulated for transitioning from the erectile condition to a flaccidcondition;

FIG. 37 is an enlarged sectional view thereof taken on the line 37--37of FIG. 35;

FIG. 38 is a simplified schematic view, partly shown in section, ofanother embodiment of the penile prosthesis in a flaccid condition;

FIG. 39 is a view similar to FIG. 38 showing the prosthesis during apumping operation for placing the prosthesis in an erectile condition;

FIG. 40 is a fragmentary detail thereof showing valve distortion duringmanipulation of the prosthesis for transitioning the prosthesis from theerectile condition of FIG. 39 to the flaccid condition of FIG. 38;

FIG. 41 is a simplified schematic view, partly shown in section, ofanother embodiment of the invention, in a flaccid condition;

FIG. 42 is an enlarged sectional view thereof taken on the line 42--42of FIG. 41;

FIG. 43 is a view similar to FIG. 41 showing the prosthesis in anerectile condition; and,

FIG. 44 is a sectional view taken on the line 44--44 of FIG. 43.

Corresponding reference characters indicate corresponding partsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

A penile prosthesis incorporating one embodiment of the invention isgenerally indicated by the reference number 10 in FIG. 1.

The prosthesis 10 comprises a proximal end portion 12, a distal endportion 14, and a main body portion 16 extending from the proximal endportion 12 to the distal end portion 14.

The prosthesis 10 has a predetermined longitudinal extent along alongitudinal axis 18, as shown dotted in FIG. 1. Further references tothe term axis or axial are intended to refer or relate to thelongitudinal axis 18.

The proximal end portion 12, which is formed of a relatively firmmedical grade elastomer such as silicone, includes a generallycylindrical section 20, a tapered conical section 22 and a rod-likemounting section 24 that extends from the tapered section 22.

The cylindrical section 20 includes a stepped end portion 26 that isjoined to an outer sleeve 28 and a coaxial inner sleeve 30 of the mainbody portion 16. The sleeves 28 and 30 are flexible but nondistensibleand can be formed of a suitable biocompatible material such as Dacronpolyester.

The distal end portion 14, which is also formed of a relatively firmmedical grade elastomer such as silicone is substantially cylindrical inshape with a conically tapered, gently curved free end 32. A pumpchamber 36 is defined within the distal end portion 14. The chamber 36has a proximally directed neck portion 38 with radially distributedopenings such as 40, 42 and 44. An annular closure flap 46 normallycloses the openings 40, 42 and 44 to prevent fluid flow into the chamber36 through the openings 40, 42 and 44.

A valve 48 extends from the neck portion 38 of the chamber 36 andincludes a ball 50 normally biased by a spring 52 against a valve seat54. The valve 48 also includes an opening 56 disposed opposite the valveseat 54. The opening 56 is communicable with the pump chamber 36 throughthe neck portion 38.

The outer sleeve 28 of the main body portion 16 is joined to a steppedportion 58 of the distal end 14, and the coaxial inner sleeve 30 isjoined to the periphery of the valve 48.

A generally cylindrical sleeve chamber 60 is defined by the inner sleeve30 and a generally annular outer sleeve chamber 62 is defined betweenthe outer sleeve 28 and the inner sleeve 30.

Filler means provided in the outer sleeve chamber 62 include a flexible,nondistensible corrugated webbing 64 as most clearly shown in FIG. 4.The webbing 64, which can be formed of Dacron mesh, is elongated in thelongitudinal axial direction. The webbing 64 has a radially innerextremity 66 joined to the inner sleeve 30 and a radially outerextremity 68 joined to the outer sleeve 28.

The prosthesis 10 is implanted in the penis (not shown) in any suitableknown manner, preferably between or within one of the corpus cavernosumof the penis. The proximal portion 12 is preferably positioned in theroot segment of the corpus cavernosum with the main body portion 16disposed within the pendulous section of the penis. The distal endportion 14 is adapted to be positioned under the glans of the penis.

A predetermined amount of fluid 70 such as isotonic saline is providedin the inner chamber 60 of the inner sleeve 30. The amount of fluid 70used in the prosthesis 10 is predetermined to ensure that there issufficient flexibility of the chamber 60 to allow the penis to assume aflaccid condition even if all the fluid 70 in the prosthesis 10 iswithin the inner sleeve chamber 60.

The outer sleeve chamber 62 is of less volume than the inner sleevechamber 60. For example, for a particular individual requirement theinner sleeve chamber can be approximately 5 to 8 ccs in volume, whereasthe outer sleeve chamber can be approximately 2.5 to 4 ccs in volume,and the pump chamber 36 is approximately 0.5 to 2 ccs in volume for aprosthesis having an axial sleeve length of approximately 10 to 12 cms.

When it is desired to place the prosthesis 10 in an erectile condition,the distal end portion 14 of the prosthesis is gently compressed by thefingers 74 and 76 to correspondingly compress the pump chamber 36.Although FIGS. 1-12 do not show the penis, it is to be understood thatmanipulation of the prostheses as described herein is through the peniletissue.

During compression of the pump chamber 36 the valve 48 remains in itsnormally closed condition with the ball 50 against the valve seat 54under the influence of the biasing spring 52. Compression of the pumpchamber 36 exerts a pressure force on the annular closure flap 46through the openings 40, 42 and 44 as indicated by the arrows 72 inFIG. 1. Thus compression of the distal portion 14 establishescommunication between the pump chamber 36 and the outer sleeve chamber62 through the openings 40, 42 and 44.

When the pump chamber 36 is decompressed as indicated by the spreadfingers 74 and 76 in FIG. 2, the pump chamber 36 is permitted to expandto its normal volume, thereby drawing the fluid 70 into the pump chamber36 from the inner sleeve chamber 60. The drawn in fluid 70 overcomes thebiasing force of the valve spring 52 against the ball 50, therebyunseating the ball 50. The fluid 70 thus flows through the valve seat54, past the valve opening 56, into the neck portion 38, foraccumulation in the pump chamber 36.

A sequential compression of the pump chamber 36 in the manner previouslydescribed causes the fluid 70 in the pump chamber 36, as shown in FIG.2, to be forced through the openings 40, 42 and 44 into the annularouter sleeve chamber 62.

As the fluid 70 is pumped into the annular outer sleeve chamber 62 andfills such chamber to capacity, the corrugated webbing 64 (FIG. 4)prevents the outer sleeve 28 from expanding beyond a predeterminedradial magnitude relative to the inner sleeve 30. The chamber 62 thushas a substantially predetermined maximum volume or capacity.

The fluid 70 that is pumped into the chamber 62 to expand the chamber toits maximum volume places the corrugated webbing 64 under tension andcauses rigidification of the chamber 62 when such chamber is filled tocapacity.

Pressure buildup in the chamber 62 is accomplished in a relatively quickfashion after the chamber is filled to capacity because the chamber 62is essentially nonexpandible beyond a predetermined radial magnitudedetermined by the inner and outer extremities 66 and 68 of the webbing64. Furthermore, a relatively small amount of fluid 70 is needed to fillthe chamber 62 since the webbing 64 functions as a filler material aswell as a means for limiting change in the radial dimension of thechamber 62 beyond the predetermined radial magnitude.

It will be noted that during the pumping of the fluid 70 from the pumpchamber 36 into the outer sleeve chamber 62, the biasing spring 52 urgesthe ball 50 into its normally seated position on the valve seat 54. Theforce of the biasing spring 52 on the ball 50 is also supplemented bythe pressure of the fluid 70 being pumped from the pump chamber 36 intothe outer sleeve chamber 62.

The outer sleeve chamber 62 thus functions as a rigidification chamberfor the prosthesis 10 enabling the prosthesis to be placed in anerectile condition as shown in dotted outline in FIG. 1.

When it is desired to have the penis assume a flaccid condition,pressure is applied to the prosthesis 10 at the valve 48 as shown by thefingers 74 and 76 in FIG. 3. Pressure applied to the valve 48 as shownin FIG. 3 distorts the configuration of the valve 48 and the neckportion 38. Thus the seal between the annular closure flap 46 and theopenings 40, 42 and 44 is broken, and the valve seat 54 is sufficientlydistorted such that the ball 50 can no longer seal against the valveseat 54. The valve 48 is thus held open when distorted.

In this manner the fluid 70 is permitted to flow from the outer sleevechamber 62 through the openings 40, 42 and 44, into the pump chamber 36for passage through the opening 56, past the valve ball 50, through thevalve seat 54 and into the inner sleeve chamber 60. Movement of thefluid 70 from the outer sleeve chamber 62 back into the inner sleevechamber 60 is further facilitated by gentle bending or manualcompression of the main body portion 16 to help force the fluid 70 fromthe outer sleeve chamber 62 into the pump chamber 36.

Another embodiment of the penile prosthesis is generally indicated bythe reference number 80 in FIGS. 5-8. The prosthesis 80 includes aproximal end portion 82, a distal end portion 84, and a main bodyportion 86. The main body portion 86 includes inner and outer sleeves 88and 90 that respectively define an inner sleeve chamber 92 and an outersleeve chamber 94. Unless otherwise stated, the structure of theprosthesis 80 is similar to that of the prosthesis 10.

The distal end portion 84 includes a pump chamber 96, a neck portion 98with openings 100, 102, 104, and a valve 106, all of which arestructurally similar to corresponding structure in the prosthesis 10.

An aggregate of nonsoluble filler material 108 is provided in the innersleeve chamber 92. The filler material 108 can be solid or flexibleinsoluble members, made of any suitable material such as metal orplastic, of regular or irregular shape such as polyhedrons, disks,rings, cylinders, rods, spheres, fibers, which are preshaped or complex,bubbles, fluid-filled balloons, liquid filled spheres, or BBs, etc.Specific examples of filler material can be silica, aluminum oxide,cellulose, carbon, titanium, crystalline salt or other suitablecrystalline material.

A predetermined volume of fluid 70 is provided in the inner sleevechamber 92 which does not pressurize the chamber 92 and permitsflexibility and bending of the chamber 92 with the aggregate 108 in amanner which corresponds to a flaccid condition of a penis.

For example, for an inner sleeve chamber of approximately 5 to 9 ccscapacity, the aggregate of material 108 would occupy approximately 4 to8 ccs and the amount of fluid 70 in the chamber 92 would occupyapproximately 1 to 2 ccs.

It should be noted that in the prosthesis 80 the outer sleeve chamber 94is free of any filler material or webbing.

In use, the prosthesis 80 is implanted in the penis in a known mannersimilar to that previously described for the prosthesis 10. When thepenis (not shown) is in a flaccid condition, the aggregate of fillermaterial 108 and the fluid 70 in the inner sleeve chamber 92 permitrelative shifting movement of individual members of the aggregate 108relative to each other.

When an erectile condition is desired, the pump chamber 96 is compressedin a manner similar to that previously described for the prosthesis 10.Compression of the pump chamber 96 causes any fluid 70 therein to passthrough the openings 100, 102 and 104 into the outer sleeve chamber 94.A sequential decompression of the distal end portion 84 allows the pumpchamber 96 to expand to its normal volume. During such expansion fluidfrom the inner sleeve chamber 92 is drawn into the pump chamber 96through the valve 106 in a manner similar to that previously describedfor the prosthesis 10.

Sequential compression of the distal end portion 84 to compress the pumpchamber 96 forces the fluid 70 in the pump chamber 96 into the outersleeve chamber 94 while the inner sleeve chamber 92 is sealed by thevalve 106.

As the fluid 70 is drawn or pumped from the inner sleeve chamber 92 andpumped into the outer sleeve chamber 94, the inner sleeve 88 constrictsor collapses around the aggregate of filler 108 binding such aggregatein a close, compact relationship to prevent any relative movementbetween the composite parts of the aggregate 108.

The aggregate material 108 is thus tightly bound by the sleeve 88 suchthat the chamber 92 becomes substantially rigid. Since the sleeve 88 issubstantially nondistensible and has a uniform axial length, theconstriction of the sleeve 88 around the aggregate 108 enables theprosthesis 80 to constrict from the flaccid condition shown in FIG. 5 toan erectile condition shown in dotted outline in FIG. 5, and in sectionin FIG. 7.

It will be noted that the prosthesis 80 is manipulated to a desirederectile posture and then fluid evacuation is obtained. The prosthesis,during fluid evacuation, assumes the manipulated erectile posture. Thuswhen the prosthesis 80 rigidifies it maintains the erectile posture andafter rigidification is completed the prosthesis sustains the erectileposture without outside manipulative support.

It will be noted that the amount of the aggregate of filler material 108in the inner sleeve chamber 92 is predetermined to ensure thatsubstantial elimination of fluid 70 from the inner sleeve chamber 92results in rigidification of the inner sleeve chamber 92. Thus, as thefluid 70 is withdrawn from the inner sleeve chamber 92, the prosthesis80 is transitioned from the flexible, flaccid condition of FIG. 5 to arigid, erectile condition of FIG. 8, which corresponds to thesubstantial elimination of fluid 70 from the inner sleeve chamber 92.

The volumetric relationships of the aggregate of filler 108, and fluid70 relative to the volumetric capacity of the inner sleeve chamber 92 ispredetermined to establish rigidification of the chamber 92 whensubstantially all of the fluid 70, which permits relative movement ofthe aggregate of filler material 108 in the inner sleeve chamber 92, hasbeen pumped from the inner sleeve chamber 92.

The rigidification of the inner chamber 92 is analogous to therigidification of a conventional bean bag by eliminating any slackvolume from the bean bag, whereby the bean bag takes on thecharacteristics of a one-piece, rigid structure.

It will also be noted that the amount of fluid present in the innersleeve chamber 92 to provide the prosthesis with the characteristics ofa flaccid penile condition can be used to fill the outer sleeve chamber94, although this is not necessary to obtain the rigidification of theprosthesis 80.

Thus an erectile condition of the prosthesis 80 can be obtained at arelatively low fluid pressure since rigidification is based upon thewithdrawal of fluid from the inner sleeve chamber 92.

The aggregate of filler material 108 in the inner sleeve chamber 92 alsooperates to limit change in the radial dimension of the inner chamberbeyond a predetermined minimum radial magnitude. The minimum radialmagnitude of the inner sleeve chamber 92 is predetermined by the amountof the aggregate of filler material 108 in the chamber 92, and theminimum radial magnitude is established when substantially all of thefluid 70 has been eliminated from the inner chamber 92.

To transition the prosthesis 80 from the erectile condition of FIG. 7 tothe flaccid condition of FIG. 5, a compressive force is applied to theprosthesis at the valve 106 to distort the valve 106 and the annularclosure flap 46 which covers the openings 100, 102 and 104. Fluid canthus flow from the outer sleeve chamber 94, through the pump chamber 96and into the inner sleeve chamber 92 in a manner similar to thatpreviously described for the prosthesis 10. A gentle manual compressionof the main body portion 86 while the valve 106 is being distorted helpsfacilitate transition of the prosthesis 80 from the erectile conditionto the flaccid condition.

Upon movement of the fluid 70 into the inner sleeve chamber 92, theunified rigidity of the aggregate of filler material 108 is altered.Movement of the fluid 70 into the inner chamber 92 and dispersal thereofamong the components of the aggregate 108 enable such components to movefreely with respect to each other and thereby restore the flexibility ofthe inner sleeve chamber 92 to a level of flexibility that is analogousto the flaccid condition of the penis.

When the compressive force is removed from the area of the valve 106,the inner sleeve chamber 92 is again sealed by the valve 106 to retainthe fluid 70. The presence of the fluid 70 in the inner sleeve chamber92 ensures such that the flaccid condition of the prosthesis 80 ismaintained until the pump chamber 96 is sequentially compressed anddecompressed in the manner previously described for transitioning theprosthesis 80 from a flaccid condition to an erectile condition.

Another embodiment of the penile prosthesis is generally indicated bythe reference number 120 in FIGS. 9-12. The prosthesis 120 isstructurally similar to the prosthesis 80 as indicated by thecorresponding reference numbers. However, the prosthesis 120 alsoincludes the corrugated webbing 122 in the outer sleeve chamber 94,arranged in a manner similar to that previously described for thecorrugated webbing 64 in the outer sleeve chamber 62 of the prosthesis10.

The prosthesis 120 thus includes filler material in both the innersleeve chamber 92 and the outer sleeve chamber 94. The inner and outersleeve chambers 92 and 94 are both capable of becoming rigidifiedsimultaneously to enable the prosthesis 122 to transition from theflaccid condition of FIG. 9 to the erectile condition of FIG. 11.

For example, in using the prosthesis 120, a predetermined amount of thefluid 70 is disposed in the inner sleeve chamber 92 with the aggregateof filler material 108 to enable the inner sleeve chamber 92 to have theflexibility of a flaccid penile condition.

With a predetermined amount of fluid 70 disposed in the inner sleevechamber 92, the outer sleeve chamber 94 is substantially devoid of thefluid 70 to enable the outer sleeve chamber to also have the flexibilityof a flaccid penile condition. Thus the flaccid condition of theprosthesis 120 corresponds to the presence of fluid 70 in the innersleeve chamber 92 and the absence of the fluid 70 from the outer sleevechamber 94.

In using the prosthesis 120 to transition the penis from a flaccidcondition to an erectile condition, the distal end 84 is compressed asshown in FIG. 9 to cause any of the fluid 70 in the pump chamber 96 topass through the openings 100, 102 and 104 into the outer sleeve chamber94.

A sequential decompression of the pump chamber 96, as shown in FIG. 10,permits the fluid 70 from the inner sleeve chamber 92 to be drawn intothe pump chamber 96 in a manner previously described for the prosthesis80. The fluid 70 drawn into the pump chamber 96 is then sequentiallypumped through the openings 100, 102 and 104 into the outer sleevechamber 94.

As the fluid 70 is withdrawn from the inner sleeve chamber 92, the innersleeve 88 constricts or collapses around the aggregate of fillermaterial 108 to cause a rigidification of the inner sleeve chamber 92. Athe fluid 70 is removed from the inner sleeve chamber 92, it issimultaneously pumped into the outer sleeve chamber 94 to cause abuildup of pressure in the outer sleeve chamber 94 in a manner similarto that previously described for the buildup of pressure and rigidity inthe outer sleeve chamber 62 of the prosthesis 10. Thus therigidification of the inner sleeve chamber and the outer sleeve chamberoccur substantially simultaneously and effect a transition of theprosthesis 120 from the flaccid condition of FIG. 9 to the erectilecondition of FIG. 10, as shown in dotted outline in FIG. 9.

Restoration of the prosthesis 120 to a flaccid condition from theerectile condition is accomplished by compressing the valve 106 in themanner shown in FIG. 11 to permit fluid to flow from the outer sleevechamber 94 through the pump chamber 96 and into the inner sleeve chamber92.

It should be noted that any pressure buildup in the outer sleeve chamber94 is substantially taken up by the webbing 122 which limits the radialexpansion of the chamber 94. Buildup of fluid pressure within thechamber 94 does not result in distension of the outer sleeve 90. Thusthe chamber 94 does not undergo a proportional radial volume expansionbased on internal pressure buildup and therefore has a predeterminedvolume. Thus volume expansion beyond a predetermined limit is nottransmitted to the penile tissue that surrounds the prosthesis.Therefore, when an erectile condition is developed using any one of theprostheses 10, 80 or 120, discomfort associated with radial volumeexpansion in penile prostheses of known construction is obviated herein.

Another embodiment of the penile prosthesis is generally indicated bythe reference number 130 in FIGS. 13-20.

Referring particularly to FIG. 14, the prosthesis 120 includes aproximal end portion 132, a distal end portion 134 and a main bodyportion 136.

The proximal end portion 132 includes a stepped end 138 which joins witha proximal end 140 of an outer sleeve 142 of the main body portion 136.

The distal end portion 134 includes a conically tapered section 143having a gently curved free end portion 144 formed from a soft, medicalgrade material such as silicone, and a generally cylindrical posteriorsection 146. The conical section 143 defines a minor hollow space 148and the cylindrical posterior section 146 defines a pump chamber 150which communicates with the minor space 148. A Dacron mesh disk 152 canbe provided within the minor space 148 to limit radial expansion of theconical end portion 144.

The cylindrical section 146 includes a stepped portion 154 that joinswith a distal end 156 of the sleeve 142. The main body portion 136 alsoincludes an inner sleeve 158 coaxial with the outer sleeve 142. Aproximal end 160 of the inner sleeve 158 joins a relatively highpressure valve 162 that extends from the proximal end portion 132. Adistal end 164 of the sleeve 158 joins to a relatively low pressurevalve 166 that extends from the distal end portion 134.

The high pressure valve 162 includes a valve housing 168 with a poppetmember 170 having a seal portion 172. The seal portion 172 is normallyengaged against a valve seat 174 under the influence of a biasing spring176. The valve seat 174 includes a valve opening 178. The valve housing168 also includes a distribution opening 180 that communicates with apassageway 182 formed in the valve housing 168. The passageway 182communicates with an outer sleeve chamber 184 defined between the innersleeve 158 and the outer sleeve 142.

The low pressure valve 166, which is a dual valve, includes spaced checkvalves 186 and 188. The check valve 186 permits outlet flow and thecheck valve 188 permitting inlet flow. The outlet check valve 186includes a hollow valve stem 190 received in a central passage 192 of avalve body 194. The valve body 194 is joined to or formed as anextension of the distal end portion 134.

The valve stem 190 is generally cylindrical in shape with an inlet port196 and an outlet passage 198. A conical, deflectable valve closure flap200 is joined to the valve stem 190 for circumferential sealingengagement with the valve body 194 along a circular path that isconcentric with the valve stem 190.

The inlet check valve 188 includes an annular deflectable shell 202 witha base portion 204 formed with an outlet opening 206. The base portion204 is joined to the valve body 194 such that the outlet opening 206communicates with the central passageway 192.

The valve body 194 is formed with at least one passageway 208 that leadsto the annular shell 202. An open end portion 210 of the annular shell202 is disposed in a stepped passageway 212 of the distal end portion134. The annular shell 202 is freely deflectable from the confines ofthe stepped passageway 212. A bushing 214 is also provided in thestepped passageway 212 spaced from the open end 210 of the annular shell202. The stepped passageway 212 and the bushing 214 disposed therein arecommunicable with the pump chamber 150 in the distal end portion 134.

The main body portion 136 which includes the outer sleeve 142 and theinner sleeve 158, also includes filler means 216 for limiting change inthe radial dimension of the inner sleeve 158. Referring particularly toFIGS. 14 and 21-26, the filler means 216 include a plurality of diskmembers 218 which can be formed of Dacron mesh with a disk thickness of0.005 to 0.010 inch. The disks 218 are spaced a predetermined distancefrom each other in an inner chamber 220 of the inner sleeve member 158.The periphery of the disks 218 are bonded or otherwise joined to thesleeve 158.

FIGS. 21-26 show in simplified schematic fashion the manner in which thedisks 218 can be joined to the sleeve 158. For example, each disk 218 isprovided with four peripheral notches 221, 222, 224 and 226. The notches221-226 are sized to accommodate support rods such as 228, 230, 232 and234 in a tight-fitting relationship. The support rods 228-234 are fixedat one end into a base plate 236, the opposite ends of the rods 228-234being free ends. The disks 218 can thus be positioned o the support rodsfor temporary retention in a predetermined spaced relationship as shownin FIG. 23. The support rods may also be of small enough diameter to pasthrough the mesh without the addition of notches.

The inner sleeve 158 is then disposed around the outside of the supportrods so as to envelop the disks 218. Such envelopment can beaccomplished by uncurling a rolled sleeve 158 in the manner shown inFIG. 23. When the sleeve 158 is fully uncurled to straddle the entirelength of the support rods 228-234 and the spaced disks 218, the baseplate 236 is placed in an oven to fuse or bond the periphery of thedisks 218 to the sleeve 158.

The support rods 228-234 are formed of a material such as stainlesssteel which does not fuse with the disks 218 or the sleeve 158 when thefusion operation takes place.

After fusion of the disks 218 to the sleeve 158 has been completed, thesleeve 158 with the disks 218 bonded thereto is removed from the supportrods 228-234 in the manner shown in FIG. 25, yielding the disk andsleeve structure of FIG. 26. Referring to FIGS. 14, 15, 17 and 20, itshould be noted that the first disk 218 at each opposite end of thesleeve 158 is recessed within the sleeve 158. Recess or clearance of thefirst disks 218 from the open ends of the sleeve 158 permits anchoringof the proximal end 160 of the sleeve 158 to the valve housing 168 andanchoring of the distal end 164 of the sleeve 158 to the valve body 194without any interference between the respective valve 162 and 166 andthe disks 218.

In using the prosthesis 130, a predetermined amount of fluid 240 whichis similar to the fluid 70, is disposed in the outer sleeve chamber 184when the prosthesis is in a flexible or flaccid condition correspondingto a flaccid penile condition as shown in FIG. 13.

When an erectile condition is desired, the penis 242 is gentlycompressed at the area of the pump chamber 150 to pump the fluid 240from the outer sleeve chamber 184 into the inner sleeve chamber 220 inthe manner shown in FIG. 15. Thus pressure exerted against the distalend portion 134 of the prosthesis 130 causes fluid 240 to pass from thepump chamber 150 through the passageway 212 into the opening 210 of theinlet check valve 188 for flow through the outlet opening 206 into thecentral passageway 192.

Fluid from the central passageway 192 enters the inlet port 196 of theoutlet check valve 186, where it is directed through the outlet passage198 into an initially sealed space 246 (FIG. 14) between the conicalflap 200 and the valve body 194. The pressure of the fluid 240 in theinitially sealed space 246 causes the conical flap 200 to deflect in themanner shown in FIG. 15 permitting the fluid 240 to flow past the outletcheck valve 186 into the inner chamber 220 of the inner sleeve 158.

A sequential decompression of the pump chamber 150, as illustrated inFIG. 17, causes the outlet check valve 186 to close and the inlet checkvalve 188 to open. Thus the fluid 240 in the outer sleeve chamber 184can flow through the passage 208 and past the deflected annular shell202 into the passageway 212 for entry into the pumping chamber 150.

The pumping cycle can then be sequentially repeated to pressurize theinner sleeve chamber 220 until the disks 218 ar placed underpredetermined tension due to the buildup of pressure in the innerchamber 220. The disks 2-8 also limit radial expansion of the innersleeve 158 beyond a predetermined radial magnitude.

During the pumping of the fluid 240 from the outer sleeve chamber 184into the inner sleeve chamber 220 and the consequential buildup ofpressure in the inner sleeve chamber 220, the prosthesis 130 transitionsfrom the flaccid condition of FIG. 13 to the erectile condition of FIG.19.

When it is desired to transition the prosthesis 130 from the erectilecondition to a flaccid condition, the pendulous portion of the penis iscompressed in the manner shown in FIGS. 19 and 20. Such compressionincreases the pressure of the fluid 240 in the inner chamber 220 to apredetermined level which causes opening of the valve 162. The increasedpressure of the fluid 240 resulting from manual force being applied tothe main body portion 136 of the prosthesis 130, causes the poppet 170of the valve 162 to unseat from the valve seat 174.

The fluid 240 is thus allowed to flow through the valve opening 178 pastthe distribution opening 180, into the passageway 182 for disposition inthe outer sleeve chamber 184. Preferably the pressure applied to themain body portion 136 of the prosthesis 130 should be intermittent topermit the fluid 240 flowing from the inner sleeve chamber 220 into theouter sleeve chamber 184 to flow past the point of pressure imposed uponthe main body portion 136.

The amount of the fluid 240 contained in the prosthesis 130, and thevolumetric capacities of the inner and outer chambers 220 and 240 arepredetermined to ensure that as the fluid 240 is removed from the innerchamber 220 for passage to the outer chamber 240 the prosthesis 130transitions from the erectile condition to the flaccid condition topermit the penis to assume a comfortable, flexible, flaccid condition.

The pressure level at which the valve 162 is actuated to open ispredetermined to exceed the normal pressure levels that the penisexperiences during intercourse. The opening pressure for the valve 162also exceeds the pressure levels that are needed in the inner sleevechamber 220 to obtain rigidification of the chamber 220 to thereby placethe prosthesis 130 in an erectile condition.

Another embodiment of the penile prosthesis is generally indicated bythe reference number 260 in FIGS. 27-32.

The prosthesis 260 includes a proximal end 262, a distal end 264 and amain body portion 266 joining the proximal and distal end portions.

The proximal end portion 262 includes a mounting section 268, areservoir section 270 and a valve 272. The reservoir section 270includes a reservoir sleeve 274 having a proximal end 276 joined to astepped portion 278 of the mounting section 268. A distal end 280 of thereservoir sleeve 274 is joined to the periphery of the valve 272.

The reservoir sleeve 274 defines a reservoir chamber 282 filled with apredetermined amount of fluid 284 similar to the fluid 70. The reservoirsleeve 274, which is formed of any suitable biocompatible material suchas Dacron, is in the shape of a bellows, as most clearly shown in FIG.28.

The distal end 264 of the prosthesis 260 includes a generallycylindrical section 286, with a tapered conical section 288 having agently curved free end 290 formed of a relatively firm, medical gradematerial such as silicone.

The main body portion 266 includes a sleeve 292 having a proximal end294 joined to the periphery of the valve 272 and a distal end 296 joinedto a stepped portion 298 of the distal end portion 264. The sleeve 292defines a sleeve chamber 300.

A plurality of disks 302 similar to the disks 218 can be provided in thechamber 300 at a predetermined spacing from each other in a mannersimilar to that previously described for the prosthesis 130.

The valve 272, which is similar to the valve 48 includes a ball 304which is normally biased against a valve seat 306 by a biasing spring308. The valve 272 also includes an opening 310 opposite the valve seat306.

In using the prosthesis 260, a predetermined amount of the fluid 284 isdisposed in the reservoir chamber 282. When the prosthesis 260 is in aflaccid condition the sleeve chamber 300 is sufficiently depleted offluid to afford the sleeve chamber 300 the desirable characteristicflexibility of a flaccid penile condition.

When it is desired to develop an erectile condition in the penis, theprosthesis 260 is moved in the protractile direction in the manner shownin FIG. 28 by moving the penis in the proximal direction indicated bythe arrow 312.

Movement of the prosthesis 260 in the direction indicated by the arrow312, by corresponding movement of the penis 242, causes thebellows-shaped reservoir sleeve 274 to axially contract. The fluid 284in the reservoir chamber 282 is thereby placed under sufficient pressureto open the valve 272. The ball 304 thus unseats from the valve seat306, enabling the fluid 284 to flow past the valve 272 into the sleevechamber 300. Movement of the prosthesis 260 in the manner previouslydescribed operates to pump the fluid 284 from the reservoir chamber 282into the sleeve chamber 300.

As previously described for the prosthesis 130, the presence of thedisks 302 in the sleeve chamber 300 prevent the sleeve chamber fromexpanding radially beyond a predetermined radial magnitude governed bythe diameter of the disks 302. The sleeve 292 thus expands to acondition where the volume of the sleeve 292 becomes fixed such thatinfusions of fluid into the sleeve 292 as the sleeve reaches fullcapacity cause rapid buildup of pressure.

The buildup of pressure in the sleeve 292 to a predetermined leveleffects a rigidification of the chamber 300 enabling the prosthesis 262to transition from the flaccid condition of FIG. 33 to the erectilecondition of FIG. 31.

When it is desired to restore the flaccid condition of the penis 242,pressure is applied through the penis to the prosthesis 260 at theregion of the valve 272. Pressure distortion of the valve 272 in themanner shown in FIG. 32 opens the valve and enables the fluid 284 in thechamber 300 to flow back into the reservoir 282. Gentle manualcompression of the sleeve 292 helps facilitate flow of the fluid 284into the reservoir 282.

When a predetermined amount of the fluid 284 has been caused to flowfrom the chamber 300 back into the reservoir 282, the main body portion266 is restored to its flexible condition to enable the penis toreassume its flaccid condition. The cycles of flaccidity and rigiditycan thus be selected at will.

Another embodiment of the penile prosthesis is generally indicated bythe reference number 320 in FIGS. 34-37.

The prosthesis 320 includes a proximal end 322, a distal end 324 and amain body section 326 adjoining the proximal and distal ends 322 and324.

The proximal end 322 includes a mounting section 328, similar to themounting section 268 of the prosthesis 260 and a reservoir section 330.A valve 332, similar to the valve 272 of the prosthesis 260 is providedat a distal end of the reservoir section 330. The reservoir section 330includes a reservoir sleeve 334 that defines a reservoir chamber 336provided with a predetermined amount of fluid 338, similar to the fluid70.

The distal end portion 324 of the prosthesis 320 includes a generallyhollow conical section 340 which defines a pumping chamber 342 Thedistal end portion 324 also includes a dual check valve 344 at aproximal end of the pump chamber 342.

The dual check valve 344 includes valve elements 346 and 348 that areidentical to the outlet check valve 186 of the prosthesis 130. The valveelements 346 and 348 are disposed in a valve body 350. Thus each of thevalve elements 346 and 348 include respective conical flaps 352 and 354.A valve passage 356 formed in the valve body 350 communicates with thevalve element 346 and a valve passage 358 in the valve body 350communicates with the valve element 348.

The main body section 326 includes a sleeve 360 that defines a sleevechamber 362. The sleeve 360 is joined at a proximal end 364 to theperiphery of a valve body 366 of the valve 332. A distal end 368 of thesleeve 360 is joined to the periphery of the valve body 350.

A plurality of flexible disks 370, similar to the disks 218, areprovided at a predetermined spacing from each other in the sleevechamber 362 in a manner similar to that previously described for theprosthesis 130. Each of the disks 370 include an opening sized toaccommodate a flexible elongated tube 372 having a proximal end 374supported in a passageway 376 of the valve body 366. The tube 372 alsoincludes a distal end 378 supported in a passageway 358 of the valvebody 350.

The valve 332 includes a spring biased ball 380 normally biased againsta valve seat 382. A valve opening 384 is provided opposite the valveseat 382.

In using the prosthesis 320, flaccid or erectile conditions can bedeveloped at will through manual manipulation of the prosthesis.

For example, assuming the prosthesis is in a flaccid condition,substantially the entire supply of fluid 338 is located in the reservoir336. When an erectile condition is desired, the penis 242 is manipulatedin the glans area 244, as shown in FIG. 34, to gently apply acompressive force to the distal end 324. Pressure applied to the distalend 324 causes compression of the pump chamber 342 which forces fluidfrom the pump chamber 342 into the passageway 356 of the valve body 350for movement past the valve element 346 into the sleeve chamber 362, asindicated by the arrow 386. Fluid entering the sleeve chamber 362 isnormally prevented from exiting the chamber 362 by the valve 332.

A sequential decompression of the pump chamber 342 establishes a suctioncondition in the pump chamber causing the valve element 348 to open toallow the fluid 338 from the reservoir chamber 336 to pass through thepassageway 376 into the tube 372 and into the passageway 358 formovement past the conical flap 352 of the valve element 348 into thepump chamber 342.

The sequential compression and decompression of the pump chamber 342results in a gradual filling of the sleeve chamber 362 to a radialexpansion limit determined by the diameter of the disks 370. The sleevechamber 362 is thus expanded to a rigidification condition, as describedfor the prosthesis 130, to transition the prosthesis 320 from theflaccid condition to an erectile condition.

When it is desired to transition the prosthesis 320 from an erectilecondition to a flaccid condition, pressure is applied to the root end ofthe penis as illustrated in FIG. 36 to distort the valve 332. Distortionof the valve 332 enables the fluid 338 in the sleeve chamber 362 to flowpast the valve 332 into the reservoir chamber 336.

It should be noted that substantially total removal of fluid from thesleeve chamber 362 can be facilitated by also gently applying manualpressure to the pendulous portion of the penis while the valve 332 isdistorted.

Another embodiment of the penile prosthesis is generally indicated bythe reference number 390 in FIGS. 38-40. The prosthesis 390 includes aproximal end 392, a distal end 394 and a main body section 396 adjoiningthe proximal end 392 and the distal end 394. The prosthesis 390 alsoincludes a pump and reservoir section 398 arranged to communicate withthe main body section 396 via a flexible conduit 400.

The proximal end 392 is formed with a passageway 402 that communicateswith the conduit 400. The proximal end 392 is otherwise formed of arelatively firm, biocompatible, medical grade material such as silicone.The distal end 394, which is also formed of a similar relatively firm,medical grade elastomer, has a generally tapered conical section 404with a gently curved free end 406.

The main body portion 396 includes a sleeve member 408 having a proximalend 410 joined to a stepped portion 412 of the proximal end portion 392.A distal end 414 of the sleeve member 408 is joined to a stepped portion416 of the distal end portion 394. The sleeve member 408 defines asleeve chamber 418 that is communicable with the passageway 402 of theproximal end 392.

A plurality of disks 420, similar to the disks 218 of the prosthesis130, are disposed in the sleeve chamber 418 at a predetermined spacingfrom each other.

The reservoir chamber 398 includes a bulb-like shell portion 422 that isflexible and compressible, and is preferably formed of a suitablebiocompatible material such as silicone. A valve 424, similar to thevalve 272 of the prosthesis 260, is joined to the reservoir shell 422.The valve 424 includes a spring biased ball 426 normally seated againsta valve seat 428, and an oppositely disposed valve opening 430 whichcommunicates with the conduit 400.

In using the prosthesis 390, the proximal end 392, the distal end 394and main body section 396 are implanted in the penis 242 in a mannersimilar to that previously described for the prosthesis 10. Thereservoir section 398 is implanted in the scrotal sac (not shown).

When the prosthesis 390 is in a flaccid condition as shown in FIG. 38,the reservoir shell 422 houses a predetermined supply of fluid 432,similar to the fluid 70, in a chamber 434 of the reservoir, and thesleeve chamber 418 is substantially devoid of fluid. A gentlecompression of the reservoir shell 422 in the manner shown in FIG. 39causes the fluid 432 to unseat the valve ball 426 from the valve seat428 thereby enabling the fluid 432 to flow through the conduit 400 intothe passageway 402 and into the sleeve chamber 418.

The reservoir shell 422 can be compressed once or, if desired, pumpedintermittently to transfer a predetermined amount of the fluid 432 intothe sleeve chamber 418. Incoming fluid enables the sleeve member 408 totransition to an erectile condition in a manner similar to thatpreviously described for the prosthesis 10. Fluid in the sleeve chamber418 is normally unable to flow back into the reservoir chamber 432because the valve 424 is a one-way check valve.

When it is desired to transition the prosthesis 390 from the erectilecondition of FIG. 39 to the flaccid condition of FIG. 38, the valve 422is gently distorted in the manner shown in FIG. 40 by applying pressurethrough the scrotal sac to the periphery of the valve 424. Distortion ofthe valve 424 unseats the ball 426 from the valve seat 428. Fluid fromthe sleeve chamber 418 can thus flow in a reverse direction through thepassageway 402, into the tube 400, past the valve 424, and into thereservoir chamber 434. The prosthesis 390 can thus be placed in anerectile condition or flaccid condition at the selection of the user.

Another embodiment of the penile prosthesis is generally indicated bythe reference number 480 in FIGS. 41-44. The prosthesis 480 includes aproximal end 482, a distal end 484 and a main body section 486. Theprosthesis 480 also includes a reservoir section 488 similar to thereservoir and pump section 398 of the prosthesis 390. The proximal end482 and the distal end 484 of the prosthesis 480 are similar to theproximal and distal ends 392 and 394 of the prosthesis 390.

The main body section 486 includes a sleeve member 490 joined to theproximal end 482 and the distal end 484 in a manner similar to thatpreviously described for the prosthesis 390. The sleeve member 490includes a sleeve chamber 492 that is provided with nonsoluble fillermembers 494 which are substantially spherical in shape. The fillermembers 494 can be formed of any suitable biocompatible plastic or metalmaterial. In addition, the filler members 494 can be liquid filledhollow spheres.

The spherical filler members 494 need not be of uniform size but can bewithin a diametrical range of approximately 0.3 cm. Preferably for asleeve chamber of approximately 1.0 cm in diameter and 12 cm in length,and having a volume of 10 to 12 cc, the approximate volume of the fillermembers provided in the chamber is approximately 8 to 11 cc.

In using the prosthesis 480, the sleeve chamber 492 is normally filledwith a fluid 496, similar to the fluid 70, when the prosthesis is in theflaccid condition. Thus the filler members 494, in the presence of thefluid 496, can shift relative to one another such that the main bodysection 486 is flexible in a manner that is analogous to the flaccidcondition of a penis. The reservoir shell 498 of the pump chamber 488 isin a generally collapsed condition when the sleeve 490 is in the flaccidcondition.

The chamber 500 of the reservoir shell 498 is at a relatively lowpressure level close to vacuum conditions and is maintained at suchrelatively low pressure level by the normally closed valve 424.

To transition the prosthesis 480 from the flaccid condition of FIG. 41to the erectile condition of FIG. 43, the valve 424 is gently distortedin the manner shown in FIG. 43. Distortion of the valve 424 causes thevalve to open and thereby permit the fluid 496 in the shell chamber 492,which is at a relatively high pressure, to flow into the reservoir andpump chamber 500 which is at a relatively low pressure. The fluid 496thus flows continuously out of the sleeve chamber 492 as long as thevalve 424 is maintained in an open condition.

The flow of the fluid 496 from the sleeve chamber 492 into the reservoir500 results in a lowering of fluid pressure in the sleeve chamber 496.The sleeve 490 thus constricts or collapses around filler members 494thereby binding such filler members together to substantially preventrelative movement between the filler members. As a result, the sleevechamber 492 rigidifies and causes the main body section 486 to assume anerectile posture as shown in FIG. 43.

When it is desired to restore the flaccid condition of the prosthesis480, the reservoir shell 498 is gently compressed, preferably in agentle continuous squeezing action, to unseat the ball of the valve 424and cause the fluid 496 to flow past the valve 424 through the conduit400 and passageway 402 into the sleeve chamber 492. The accumulation offluid 496 in the sleeve chamber 492 expands the sleeve 490 giving thefiller members room to move relative to each other thereby restoring theflexible condition of the sleeve member 490 and enabling the penis 242to assume the flaccid condition shown in FIG. 41.

Some advantages of the present invention evident from the foregoingdescription include a penile prosthesis that can assume an erectileposture at substantially little or no pressure within the prosthesis.The prosthesis includes filler members for limiting change in the radialdimension of the penile prosthesis chamber as by limiting radialexpansion in some embodiments and radial contraction in otherembodiments.

The embodiments which have an expandable limit can achieve an erectilecondition by pumping fluid into a chamber until the filler memberstherein are placed under tension to maintain the chamber at asubstantially fixed volume. When the chamber is substantially full,small additions of fluid can cause a rapid pressure rise due to thenondistensible characteristics of the chamber walls.

The prosthesis includes provision for pumping at a proximal end portionusing axially reciprocative movement. In other embodiments theprosthesis can be pumped at a distal end portion using sequentialcompression and decompression of a pump chamber, and in otherembodiments a pumping chamber is located in a scrotal sac.

Since the pressure within the prosthesis in some embodiments is taken upby filler members that restrict radial expansion of the prosthesis,pressures imposed within the prosthesis are not entirely transferred tothe surrounding penile tissue. Thus the comfort of such prostheses isenhanced. In other embodiments where the absence of fluid pressure andexpulsion of fluid is a factor in achieving an erectile condition,little if any fluid pressure is imposed on the penile tissue surroundingthe prosthesis. Thus greater comfort levels are achieved using thedisclosed prostheses than in prostheses that derive rigidity based on ahigh pressure expansion of an inner chamber.

A further advantage is that the user can select at will a flaccid orerectile condition of the penis.

In view of the above, it will be seen that the several objects of theinvention are achieved and other advantageous results attained.

As various changes can be made in the above constructions and methodwithout departing from the scope of the invention, it is intended thatall matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative and not in alimiting sense.

What is claimed is:
 1. A penile prosthesis comprising a normally flaccid but selectively rigidifiable axially elongate main body portion, a proximal end portion extending from a corresponding proximal end of the main body portion, and a distal end portion extending from a corresponding distal end of said main body portion, said main body portion including at least one chamber for receiving fluid, filler means in said one chamber to reduce the fluid fill capacity of said one chamber, said filler means being positioned in said one chamber such that fluid in said one chamber contacts said filler means, pumping means communicable with said one chamber and actuatable for pumping fluid in a predetermined fluid flow direction between said one chamber and said pumping means, and valve means disposed between said pumping means and said one chamber and cooperable with said pumping means for controlling the predetermined fluid flow direction between said one chamber and said pumping means during actuation of said pumping means such that movement of said fluid in said predetermined fluid flow direction in response to activation of said pumping means causes rigidification of said one chamber, and wherein said filler means is disposed in said one chamber to extend radially across said one chamber to prevent change in the radial magnitude of said one chamber in a predetermined radial direction when said one chamber is rigidified.
 2. The penile prosthesis as claimed in claim 1 wherein said pumping means are provided in said proximal end portion.
 3. The penile prosthesis as claimed in claim 2 wherein said pumping means is in the form of a bellows that is axially contractible along the axis of said elongated main body portion during actuation of said pumping means.
 4. The penile prosthesis as claimed in claim 1 wherein the pumping means are provided in said distal end portion.
 5. The penile prosthesis as claimed in claim 1 wherein a conduit joins said pumping means and said distal end portion such that said pumping means is communicable with said one chamber through said conduit.
 6. A penile prosthesis comprising a normally flaccid but selectively rigidifiable axially elongate main body portion, a proximal end portion extending from a corresponding proximal end of the main body portion, and a distal end portion extending from a corresponding distal end of said main body portion, said main body portion including at least one chamber having a predetermined volumetric capacity, filler means in said one chamber for taking up a first predetermined portion of said volumetric capacity, said one chamber further including a fluid fillable space representing a second predetermined portion of said volumetric capacity wherein said first and second predetermined portions of said volumetric capacity are substantially equivalent to the predetermined volumetric capacity of said one chamber, pumping means communicable with said one chamber and actuatable for pumping fluid in a predetermined direction between said fluid fillable space and said pumping means, and valve means disposed between said pumping means for controlling the predetermined direction of flow of fluid between said one chamber and said pumping means during actuation of said pumping means such that movement of said fluid in said predetermined direction in response to activation of said pumping means causes rigidification of said one chamber, and wherein said filler means includes means for limiting change in the radial magnitude of said one chamber beyond a predetermined amount when said chamber is rigidified, and wherein said one chamber is defined by a flexible, collapsible, nondistensible sleeve member and said means for limiting change in the radial magnitude of said one chamber include means for limiting the radial expansion of said sleeve member beyond a predetermined limit, and wherein said means for limiting radial expansion of said sleeve member include at least one filler member having an outer periphery substantially radially coextensive with and joined to said sleeve member, said sleeve member being generally cylindrical and said filler means including a plurality of spaced reinforcing disks having a diameter substantially equivalent to the diameter of said sleeve member and a peripheral portion joined to said sleeve member.
 7. The penile prosthesis as claimed in claim 6 wherein said disks include openings to permit flow of fluid through said disks.
 8. A penile prosthesis comprising a normally flaccid but selectively rigidifiable axially elongate main body portion, a proximal end portion extending from a corresponding proximal end of the main body portion, and a distal end portion extending from a corresponding distal end of said main body portion, said main body portion including at least one chamber having a predetermined volumetric capacity, filler means in said one chamber for taking up a first predetermined portion of said volumetric capacity, said one chamber further including a fluid fillable space representing a second predetermined portion of said volumetric capacity wherein said first and second predetermined portions of said volumetric capacity are substantially equivalent to the predetermined volumetric capacity of said one chamber, pumping means communicable with said one chamber and actuatable for pumping fluid in a predetermined direction between said fluid fillable space and said pumping means, and valve means disposed between said pumping means and said one chamber and cooperable with said pumping means for controlling the predetermined direction of flow of fluid between said one chamber and said pumping means during actuation of said pumping means such that movement of said fluid in said predetermined direction in response to activation of said pumping means causes rigidification of said one chamber, and wherein said filler means includes means for limiting change in the radial magnitude of said one chamber beyond a predetermined amount when said chamber is rigidified, and wherein said one chamber is defined by a flexible, collapsible, nondistensible sleeve member and said means for limiting change in the radial magnitude of said one chamber include means for limiting the radial expansion of said sleeve member beyond a predetermined limit, and wherein said prosthesis includes a second chamber substantially coaxial with said one chamber, and adapted to communicate with said pumping means such that movement of fluid in said predetermined direction in response to activation of said pumping means flows between said one and second chambers.
 9. The penile prosthesis as claimed in claim 8 wherein said means for limiting change in the radial dimension of said one chamber include a filler member comprising an axially elongated webbing having an elongated extremity substantially axially coextensive with said one chamber and joined to said sleeve member.
 10. The penile prosthesis as claimed in claim 9 wherein said one chamber is of annular form in cross section and is defined by outer and inner coaxial sleeve members, and said webbing has a radially outer elongated extremity joined to the outer sleeve member, and a radially inner elongated extremity joined to the inner sleeve member.
 11. The penile prosthesis as claimed in claim 8 wherein said webbing is corrugated, said corrugation being distributed radially around the axis of said one chamber such that the radially outer elongated extremity includes radially outer folds joined to the outer sleeve member, and the radially inner extremity includes radially inner folds joined to the inner sleeve member.
 12. The penile prosthesis as claimed in claim 8 wherein said one chamber is substantially cylindrical and said second chamber is substantially annular.
 13. The penile prosthesis as claimed in claim 8 wherein said one chamber is substantially annular and said second chamber is substantially cylindrical.
 14. The penile prosthesis as claimed in claim 8 wherein said one chamber is defined by a flexible, collapsible, substantially nondistensible sleeve member and said means for limiting change in the radial dimension of said one chamber includes means for limiting the radial collapse of said sleeve member.
 15. The penile prosthesis as claimed in claim 14 wherein said one chamber is substantially cylindrical in cross-section.
 16. The penile prosthesis as claimed in claim 8 wherein the pumping means are provided in said distal end portion;
 17. The penile prosthesis as claimed in claim 10 wherein a conduit joins said pumping means and said distal end portion such that said pumping means is communicable with said one chamber through said conduit.
 18. A penile prosthesis comprising a normally flaccid but selectively rigidifiable axially elongate main body portion, a proximal end portion extending from a corresponding proximal end of the main body portion, and a distal end portion extending from a corresponding distal end of said main body portion, said main body portion including at least one chamber having a predetermined volumetric capacity, filler means in said one chamber for taking up a first predetermined portion of said volumetric capacity, said one chamber further including a fluid fillable space representing a second predetermined portion of said volumetric capacity wherein said first and second predetermined portions of said volumetric capacity are substantially equivalent to the predetermined volumetric capacity of said one chamber, pumping means communicable with said one chamber and actuatable for pumping fluid in a predetermined direction between said fluid fillable space and said pumping means, and valve means disposed between said pumping means and said one chamber and cooperable with said pumping means for controlling the predetermined direction of flow of fluid between said one chamber and said pumping means during actuation of said pumping means such that movement of said fluid in said predetermined direction in response to activation of said pumping means causes rigidification of said-one chamber, and wherein said filler means includes means for limiting change in the radial magnitude of said one chamber beyond a predetermined amount when said chamber is rigidified, and wherein said one chamber is defined by a flexible, collapsible, substantially nondistensible sleeve member and said means for limiting change in the radial dimension of said one chamber includes means for limiting the radial collapse of said sleeve member, said means for limiting the radial collapse of said sleeve member includes an aggregate of filler members taking up said first predetermined portion of said volumetric capacity such that fluid in said one chamber can take up said second predetermined portion of said volumetric capacity to enable said filler members to move relative to each other and afford axial flexibility to said one chamber corresponding to a flaccid penile condition.
 19. The penile prosthesis as claimed in claim 18 wherein said pumping means is actuatable to cause movement of fluid in said predetermined direction away from said one chamber and said sleeve member has a predetermined flexibility to radially collapse around said filler members such that said collapsed sleeve member binds said filler members together thereby constricting said filler members from relative movement with respect to each other to cause rigidification of said one chamber.
 20. The penile prosthesis as claimed in claim 18 wherein said filler members are of regular shape.
 21. The penile prosthesis as claimed in claim 18 wherein said filler members are of irregular shape.
 22. The penile prosthesis as claimed in claim 18 wherein said filler members are rigid.
 23. The penile prosthesis as claimed in claim 18 wherein said filter members are solid.
 24. The penile prosthesis as claimed in claim 18 wherein said filler members are fluid filled.
 25. A penile prosthesis comprising a normally flaccid but selectively rigidifiable comprising a normally flaccid but selectively rigidifiable axially elongate main body portion, a proximal end portion extending from a corresponding proximal end of the main body portion, and a distal end portion extending from a corresponding distal end of said main body portion, said main body portion including at least one chamber having a predetermined volumetric capacity, filler means in said one chamber for taking up a first predetermined portion of said volumetric capacity, said one chamber further including a fluid fillable space representing a second predetermined portion of said volumetric capacity wherein said first and second predetermined portions of said volumetric capacity are substantially equivalent to the predetermined volumetric capacity of said one chamber, pumping means communicable with said one chamber and actuatable for pumping fluid in a predetermined direction between said fluid fillable space and said pumping means, and valve means disposed between said pumping means and said one chamber and cooperable with said pumping means for controlling the predetermined direction of flow of fluid between said one chamber and said pumping means during actuation of said pumping means such that movement of said fluid in said predetermined direction in response to activation of said pumping means causes rigidification of said one chamber, and wherein said filler means includes means for limiting change in the radial magnitude of said one chamber beyond a predetermined amount when said chamber is rigidified, and wherein said one chamber is defined by a flexible, collapsible, substantially nondistensible sleeve member and said means for limiting change in the radial dimension of said one chamber includes means for limiting the radial collapse of said sleeve member, said one chamber being substantially cylindrical in cross-section, said prosthesis including a second chamber substantially coaxial with said one chamber, and adapted to communicate with said pumping means such that movement of fluid in said one direction in response to actuation of said pumping means flows between said one and second chambers.
 26. The penile prosthesis as claimed in claim 25 including inner and outer coaxial sleeve members and wherein said one chamber is substantially cylindrical and is defined by the inner sleeve member and said second chamber is substantially annular and is defined by the space between the inner and outer sleeve members.
 27. The penile prosthesis as claimed in claim 26 further including a second filler material in said second chamber, said second filler material comprising a webbing joined to said inner and outer sleeve members.
 28. The penile prosthesis as claimed in claim 27 wherein said webbing has a radially outer elongated extremity joined to the outer sleeve member, and a radially inner elongated extremity joined to the inner sleeve member.
 29. The penile prosthesis as claimed in claim 28 wherein said webbing is corrugated, said corrugations being distributed radially around the axis of said inner sleeve such that the radially outer elongated extremity includes radially outer folds joined to the outer sleeve member, and the radially inner extremity includes radially inner folds joined to the inner sleeve member.
 30. The penile prosthesis as claimed in claim 29 wherein said webbing is axially coextensive with said second chamber.
 31. A method of selectively establishing a rigid condition in a penile prosthesis having an axially elongated chamber with a flexible wall comprising,a. incorporating filler material in said chamber to limit change in radial magnitude of said chamber beyond a predetermined amount, b. causing fluid to move in a predetermined direction between the chamber and a pump in response to actuation of the pump to enable the filler material to cooperate to the movement of fluid and establish a rigid condition in said chamber, c. attaching the filler material to the wall of the chamber to restrict radial expansion of the chamber beyond a predetermined magnitude, d. pumping fluid into the chamber to effect a radially expanded limit condition of the chamber determined by the radial extent of the filler material to cause rigidification of the chamber and the prosthesis, e. disposing an aggregate of filler material into the chamber to restrict radial collapse of the chamber, f. disposing fluid into the chamber to maintain sufficient space in the chamber to permit free movement of the constituents of the aggregate of filler material in the chamber and, g. thereafter moving fluid out of the chamber to cause the wall of the chamber to collapse against and bind the filler material together and thereby prevent free movement of the filler material in the chamber to cause rigidification of the chamber and the prosthesis. 